Ağır Karaciğer Yetmezliği Olan Hastalarda Gen Düzenlenmiş Domuz Karaciğerinin Vücut Dışı Perfüzyonu

Sade dilde özet

Bu çalışma, altı geni düzenlenmiş domuz karaciğerinin vücut dışında kan dolaşımına bağlanması (ex vivo perfüzyon) yöntemini ve çok ilaçlı bağışıklık baskılayıcı tedaviyi, ağır karaciğer yetmezliği (severe hepatic failure) olan hastalarda incelemektedir. Çalışmaya, 18-70 yaş arası, ağır karaciğer yetmezliği tanısı olan ve işleme dayanabilecek durumda olan hastalar alınmaktadır. Erken Faz 1 aşamasında yürütülmektedir; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Erken Faz 1 (Early Phase 1)

Durum

Devam ediyor, katılım kapalı

Sponsor

Xijing Hospital

Müdahale

Ex vivo perfusion of six-gene-edited porcine liver, Multi-drug immunosuppressive therapy

Başlangıç

31.01.2026

Tahmini bitiş

31.12.2026

Ülkeler

China

İlgili genler

Merkezler

• Xi'an, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Age and Gender: Adults aged 18-70 years, any gender.
* Diagnosis of Severe Hepatic Failure: Patients meeting diagnostic criteria from the "Guidelines for Diagnosis and Treatment of Hepatic Failure (2024 Edition)" including:

Acute liver failure: Acute onset without underlying liver disease history, developing grade II or higher hepatic encephalopathy within 4 weeks Subacute liver failure: Acute onset without prior liver disease, clinical manifestations of liver failure appearing within 4-24 weeks Acute-on-chronic liver failure: Acute deterioration of liver function on the basis of chronic liver disease (with or without cirrhosis), presenting as liver and/or extrahepatic organ failure with high short-term mortality (28-day mortality ≥15%) Chronic liver failure: Progressive liver function decline on the basis of cirrhosis resulting in chronic hepatic decompensation (recurrent ascites and/or hepatic encephalopathy) All patients must have: Grade II or higher hepatic encephalopathy, confirmed by a third-party independent expert panel of three members assessing poor treatment response and extremely high short-term mortality risk.

* Surgical Tolerance: Other organs besides the liver must be able to tolerate the trauma of extracorporeal liver perfusion surgery.
* Informed Consent: Parents, spouses, and adult children (immediate family members) must be fully informed and voluntarily sign the informed consent form, with ability to complete the trial as required by the protocol.

Exclusion Criteria:

* Immune Dysfunction: Individuals with HIV infection, diagnosed systemic immune diseases, or those undergoing immunosuppressive therapy affecting systemic immune function.
* Prior Transplantation: Previous recipients of allogeneic tissue or organ transplantation.
* Religious/Ethnic Restrictions: Individuals who cannot accept swine-derived materials due to religious beliefs, ethnic considerations, or other reasons.
* Recent Trial Participation: Participation in other clinical studies within 3 months prior to enrollment.
* Surgical Contraindications: Pathological changes at the planned operative site rendering surgery inoperable, or presence of critical organ failure or systemic severe infections precluding surgical intervention.
* Investigator Discretion: Patients deemed unsuitable for participation by the investigator for other reasons.